关于完善我国非处方药上市路径管理的建议

doi:10.16153/j.1002-7777.2020.11.004

中国药事 ›› 2020, Vol. 34 ›› Issue (11) : 1269-1274. DOI: 10.16153/j.1002-7777.2020.11.004

非处方药管理制度研究专栏

关于完善我国非处方药上市路径管理的建议

杨建红¹, 张彦彦¹, 陈江鹏¹, 陶巧凤², 汪鳌³, 贾颖君⁴, 孟晓峰⁵, 叶真⁶, 李丽华⁷, 王冬妮⁸, 黎泽琳⁹, 陈震¹⁰

作者信息 +

Suggestions on Improving China's OTC Market Path System

Yang Jianhong¹, Zhang Yanyan¹, Chen Jiangpeng¹, Tao Qiaofeng², Wang Ao³, Jia Yingjun⁴, Meng Xiaofeng⁵, Ye Zhen⁶, Li Lihua⁷, Wang Dongni⁸, Li Zelin⁹, Chen Zhen¹⁰

Author information +

文章历史 +

摘要

目的：为完善我国非处方药上市路径管理提供参考。方法：基于对国内外非处方药上市路径管理的对比研究结果，结合问卷调研结果进行综合分析。结果与结论：从药品全生命周期管理的角度，提出了完善我国非处方药上市路径管理的建议，包括建立单独的非处方药注册审评审批程序、完善非处方药转换管理制度、探索我国非处方药专论制度等。

Abstract

Objective: To provide a reference for improving the management of marketing paths for OTC drugs in China. Methods: Based on the results of comparative study on the management of OTC drug marketing paths at home and abroad, combined with the results of questionnaire surveys, a comprehensive analysis was conducted. Results and Conclusion: From the perspective of drug life cycle management, suggestions for improving the management of marketing paths for OTC drugs in China are put forward in this article, such as establishing a separated OTC drug registration review and approval procedure, improving the management of Rx-to-OTC switch, and exploring the OTC drug monograph system in China and so on.

导出引用

杨建红, 陶巧凤, 汪鳌, 贾颖君, 孟晓峰, 叶真, 李丽华, 王冬妮, 张彦彦, 陈江鹏, 黎泽琳, 陈震. 关于完善我国非处方药上市路径管理的建议[J]. 中国药事, 2020, 34(11): 1269-1274 https://doi.org/10.16153/j.1002-7777.2020.11.004

Yang Jianhong, Tao Qiaofeng, Wang Ao, Jia Yingjun, Meng Xiaofeng, Ye Zhen, Li Lihua, Wang Dongni, Zhang Yanyan, Chen Jiangpeng, Li Zelin, Chen Zhen. Suggestions on Improving China's OTC Market Path System[J]. Chinese Pharmaceutical Affairs, 2020, 34(11): 1269-1274 https://doi.org/10.16153/j.1002-7777.2020.11.004

参考文献

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